- Hologic (Marlborough, MA)
- …a visionary leader with a passion for ensuring the highest standards of quality in medical device design and development? We are seeking a dynamic **Director of ... in FDA Quality System Regulations, especially Design Control requirements, ISO 13485, and Medical Device Directive. + Familiarity with ISO 14970, IEC 60601, IEC… more
- ConvaTec (Lexington, MA)
- …to 10 years of clinical trial management experience in conducting and leading global medical device clinical trials, preferably with a sponsor company. + Solid ... **About Convatec** **Pioneering trusted medical solutions to improve the lives we touch:**...trials, ensuring they are conducted efficiently, effectively, and in compliance with all relevant regulations including ICH GCP guidelines,… more
- Hologic (Marlborough, MA)
- …Management), and EU MDR (Regulation 2017/745). + Advanced understanding of medical device standards, including usability, reliability, electrical safety, and ... take the lead in ensuring the safety, reliability, and compliance of life-changing medical devices? At Hologic,...Assurance, Quality Engineering, or related technical roles within the medical device industry with a Bachelor's degree… more
- Philips (Cambridge, MA)
- …fit if:** + You have a minimum of 10+ years' Clinical Operations experience within Medical Device Clinical Research and FDA regulated OEM Medical Device ... planning and generation, Clinical PIL tools, process implementation, ensuring compliance with applicable laws, regulations, and standards. + Ensures accountability… more
- Oracle (Boston, MA)
- …role plays a critical part in ensuring the reliability, security, and regulatory compliance of medical devices, mobile devices, printers, and other equipment ... + Oversee and manage sustainment and support activities for hardware and medical devices across government healthcare facilities documenting and tracking risks and… more
- Hologic (Marlborough, MA)
- …verification/testing strategies to ensure compliance with QMS standards. + Own compliance strategy for the medical device portfolio, including standards ... Engineering, or Biomedical Engineering. + 8+ years of experience in the medical device industry, preferably sustaining complex capital products. + Demonstrated… more
- BJs Wholesale Club (South Attleboro, MA)
- …jury duty leave.* + Flexible and Affordable Health Benefits: Choose from three medical plans, and access optional dental, vision, Health Savings Account (HSA), and ... assigned. Support the application of club policies, procedures and compliance . + We strive for flawless execution and hold...merchandise from a pick list. Utilizes a handheld scanner device (RF) device to pick orders from… more
- Oracle (Boston, MA)
- …and AI-enabled population health platform. As HDI accelerates readiness for MDR ( Medical Device Regulation), AI regulatory requirements, and emerging global ... infrastructure meet strict global standards for security, privacy, MDR compliance , and AI safety. **Responsibilities** **What You Will Do**...Tech)** + Experience with one or more: + MDR ( Medical Device Regulation) + ISO 14971 (risk… more
- Olympus Corporation of the Americas (Westborough, MA)
- …+ Minimum of 2 years' experience in Agile development. + Experience in medical device development. + Exceptional analytical and conceptual thinking skills. + ... **Preferred:** + Minimum of 1 year experience in Healthcare Medical Device or Medical IT...where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core… more
- Teradyne (North Reading, MA)
- …powering next-generation technologies through sophisticated solutions. Behind every electronic device you use, Teradyne's test technology ensures your device ... and delivers better business results. Opportunity Overview Teradyne's Product Safety and Compliance Team is seeking a Product Safety Engineer with deep expertise in… more